Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack

Coronary Artery Disease Clinical Trial

— OCT-RISK  

Official title:

Optical Coherence Tomography With Magnetic Resonance Angiography to Assess STEMI Non-culprit Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781087
• Other study ID #: 292740
• Secondary ID: FS/CRTF/22/24342
• Status: Recruiting
• Start date: April 25, 2023
• Est. completion date: July 2027

Study information

• Verified date: September 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Matthew Li Kam Wa, MBBS
• Phone: 02071887188
• Email: mlikamwa[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Heart attacks caused by the complete blockage of a heart artery are treated by opening it with a stent. However, most people will also have 'non-culprit' narrowings found in their other arteries at this time. Although in general people do better if these non-culprit narrowings are also treated with stents if they look severe, this process has problems. This is because narrowings that look severe may be stable and not cause any trouble. For these people a stent is a wasted procedure and unnecessary risk. On the other hand, narrowings that are currently left alone because they appear mild, may progress and cause a heart attack. Participants who have had a heart attack will have a scan from inside the heart arteries during an angiogram (optical coherence tomography, OCT) and a magnetic resonance angiogram (MRA). If the investigators can show that it is possible to accurately predict which non-culprit narrowings are going to progress and which are going to stabilise, medical professionals may be able to better target their treatments after a heart attack.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2027
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Successful primary percutaneous coronary intervention (PCI) within the previous week with no major complications at the index procedure
• Bystander disease in a non-culprit vessel planned for clinically indicated staged angiography +/- PCI
• Able to provide written informed consent.

Exclusion Criteria:

• Cardiogenic shock requiring intubation, inotropes or a mechanical support device
• Creatinine clearance <30ml/min
• Prior coronary artery bypass grafting
• Life expectancy less than 3 years
• Pregnancy.
• Target lesion in the left main coronary artery
• Severe calcification or tortuosity that would threaten safe placement of a pressure wire or OCT catheter
• Chronic total occlusion of a major epicardial vessel.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• ST Elevation Myocardial Infarction

Intervention

Diagnostic Test:
• Optical coherence tomography and pressure wire assessment
Non-culprit coronary arteries
• Cardiac magnetic resonance angiogram
1.5T

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London
United Kingdom	St Thomas' Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College Hospital NHS Trust, King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Non-culprit major adverse cardiac events	Death, myocardial infarction, ischaemia driven revascularisation	6 months and 36 months
Other	Change in vessel stenosis measured by optical coherence tomography and magnetic resonance angiography	Comparison between non-invasive and invasively derived measures	0, 6 and 36 months
Primary	Change in mean fibrous cap thickness measured by optical coherence tomography		6 months
Secondary	Change in mean lipid arc measured by optical coherence tomography		6 months
Secondary	Presence of thin cap fibroatheroma measured by optical coherence tomography	Plaque with lipid arc >90° and fibrous cap thickness =65µm	6 months
Secondary	Change in measures of shear stress made by optical coherence tomography and magnetic resonance angiography	Comparison between non-invasive and invasively derived measures	0 and 6 months